Pembrolizumab

Generic Name
Pembrolizumab
Brand Names
Keytruda
Drug Type
Biotech
Chemical Formula
-
CAS Number
1374853-91-4
Unique Ingredient Identifier
DPT0O3T46P
Background

Pembrolizumab is a highly selective IgG4-kappa humanized monoclonal antibody against PD-1 receptors. It was generated by grafting the variable sequences of a very high-affinity mouse antihuman PD-1 antibody onto a human IgG4-kappa isotype containing a stabilizing S228P Fc mutation. It contains 32 cysteine residues and the complete folded molecule includes 4 ...

Indication

Pembrolizumab is indicated for the following conditions:

For all approved adult indications, pembrolizumab may be used for an additional 6 weeks at 400mg weekly.

Associated Conditions
Advanced Endometrial Cancer, Advanced Renal Cell Carcinoma, Hepatocellular Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma, Locally Advanced or Metastatic Urothelial Carcinoma (UC), Metastatic Adenocarcinoma of the Gastroesophageal Junction, Metastatic Cervical Cancer, Metastatic Esophageal Carcinoma, Metastatic Melanoma, Metastatic Non-Small Cell Lung Cancer, Metastatic Renal Cell Carcinoma ( mRCC), Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), Metastatic Triple Negative Breast Cancers, Metastatic Urothelial Carcinoma (UC), Metastatic cutaneous squamous cell carcinoma, Metastic Renal Cell Carcinoma, Non-Small Cell Lung Cancer (NSCLC), Nonsmall Cell Lung Cancer, Stage II, Persistent Cervical Cancer, Recurrent Cervical Cancer, Refractory Primary Mediastinal Large B-Cell Cell Lymphoma, Renal Cell Carcinoma (RCC), Resectable Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIB Melanoma, Stage IIC Melanoma, Stage III Melanoma, Stage IIIA Non Small Cell Lung Cancer, Unresectable Melanoma, Advanced Microsatellite Instability High Endometrial Carcinoma, Advanced Mismatch Repair-deficient (dMMR) Endometrial Carcinoma, High risk, early Triple Negative Breast Cancer, High risk, in situ Non-Muscle Invasive Bladder Cancer (NMIBC) Refractory to BCG, Locally advanced Adenocarcinomas of the Gastroesophageal Junction, Locally advanced Esophageal Carcinoma, Locally advanced Urothelial Carcinoma, Metastatic HER2-positive Adenocarcinoma of the Stomach, Metastatic HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Metastatic High Tumor Mutation Burden Solid Tumors, Metastatic Merkel Cell Carcinoma (MCC), Metastatic Microsatellite Instability High Colorectal Cancer, Metastatic Microsatellite Instability-High (MSI-H) Solid Tumors, Metastatic Mismatch Repair Deficient Colorectal Cancer, Metastatic Mismatch repair deficient (dMMR) solid tumors, Recurrent Cutaneous Squamous Cell Carcinoma, Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN), Recurrent, locally advanced Adenocarcinomas of the Gastroesophageal Junction, Recurrent, locally advanced Merkel Cell Carcinoma, Refractory Classical Hodgkin's Lymphoma, Relapsed Classical Hodgkin's Lymphoma, Stage 3 Non-Small Cell Lung Carcinoma (NSCLC), Unresectable High Tumor Mutation Burden Solid Tumors, Unresectable Microsatellite Instability High Colorectal Cancer, Unresectable Microsatellite Instability-High (MSI-H) Solid Tumors, Unresectable Mismatch Repair Deficient Colorectal Cancer, Unresectable Mismatch repair deficient (dMMR) solid tumors, Unresectable, locally advanced HER2-positive Adenocarcinoma of the Stomach, Unresectable, locally advanced HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Unresectable, locally recurrent Triple Negative Breast Cancer, Unresectable, recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Associated Therapies
-

Pembrolizumab After ASCT for Hodgkin Lymphoma, DLBCL and T-NHL

First Posted Date
2015-02-13
Last Posted Date
2023-07-27
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
82
Registration Number
NCT02362997
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

and more 3 locations

Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Urothelial Bladder Cancer

First Posted Date
2015-01-30
Last Posted Date
2019-09-10
Lead Sponsor
Acerta Pharma BV
Target Recruit Count
78
Registration Number
NCT02351739
Locations
🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

🇺🇸

University of Chicago, Chicago, Illinois, United States

🇺🇸

James Cancer Hospital, Columbus, Ohio, United States

and more 3 locations

Consolidation Pembrolizumab Following Chemoradiation in Patients With Inoperable/Unresectable Stage III NSCLC

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-01-22
Last Posted Date
2023-09-13
Lead Sponsor
Nasser Hanna, M.D.
Target Recruit Count
93
Registration Number
NCT02343952
Locations
🇺🇸

Fort Wayne Oncology & Hematology, Inc., Fort Wayne, Indiana, United States

🇺🇸

Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States

🇺🇸

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

and more 12 locations

Pembrolizumab in Treating Patients With Recurrent Glioblastoma

First Posted Date
2015-01-14
Last Posted Date
2024-03-22
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
18
Registration Number
NCT02337686
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Pembrolizumab +/- Bevacizumab for Recurrent GBM

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-01-13
Last Posted Date
2020-12-22
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
80
Registration Number
NCT02337491
Locations
🇺🇸

University of California, Los Angeles, Los Angeles, California, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 5 locations

A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)

First Posted Date
2015-01-07
Last Posted Date
2024-12-06
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
370
Registration Number
NCT02332668
Locations
🇺🇸

Call for Information (Investigational Site 0019), Aurora, Colorado, United States

🇺🇸

Call for Information (Investigational Site 0026), Boston, Massachusetts, United States

🇺🇸

Call for Information (Investigational Site 0031), New York, New York, United States

and more 11 locations

Study of Pembrolizumab Plus Chemotherapy in Patients With Advanced Cancer (PembroPlus)

First Posted Date
2015-01-06
Last Posted Date
2018-07-02
Lead Sponsor
Western Regional Medical Center
Target Recruit Count
81
Registration Number
NCT02331251
Locations
🇺🇸

Cancer Treatment Center of America @ Western Regional Medical Center, Goodyear, Arizona, United States

🇺🇸

Western Regional Medical Center, Goodyear, Arizona, United States

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